Research On Risk Identification And Controllability Of New Drug Research And Development Projects Based On Kano Model

ObjectivesIn view of the trend of comprehensive risk management and internal control integration,combined with the necessity of risk management of new drug R&D project and the feasibility of Kano quality classification method in risk management research,this paper constructs the risk factor set of new drug research and development project through literature research,Based on the study of the definition and structure of the Kano quality model,the Kano risk attribute classification method is proposed to classify the risk factors,and the risk of serious and the degree of control can be realized by the experts of drug research and development and risk management.Control evaluation,risk response measures to ensure the smooth development of risk internal control activities to promote the success of R&D projects with minimal management costs to achieve the most effective risk control.The research results are of great practical significance and practical value to enhance the R&D capability and risk internal control ability of new drug risk medicine enterprises,to optimize the allocation of risk management resources and to meet the demand of consumer drugs.MethodsIn this study,the risk factors of new drug research and development projects were classified and screened by literature analysis method.Risk factors were established.Questionnaires were used to understand the awareness of risk factors on project impact degree.Using Kano model,R&D staff to risk factors management awareness,according to "risk factors management to improve patient satisfaction is to promote the role of" to determine whether the risk factors need to be effectively managed from the perspective of risk management risk classification qualitative evaluation research;Consulting law to achieve the new drug research and development projects of the internal control of the key points of the consequences of serious,controlled degree of investigation,according to the experts on the plate familiarity and judgments based on the score of the total authority of the proportion of the weight set to form the risk of internal control key seriousness,Controllability research;risk attribute classification and sorting results combined with the severity and controllability analysis,the risk management strategy research.ContentThe study from the technical risk,financial risk,management risk,environmental risk,production risk,market risk point of view divided six risk factors for drug research and development projects,to build risk factors set this study;study the definition and classification of Kano quality model The method was applied to the Kano two-dimensional risk attribute model.The questionnaire was designed by using the two-dimensional characteristic of the model to investigate the relationship between the R&D personnel of the new drug and the influence of the project risk factor management on improving the patient's satisfaction.From the risk management effectiveness dimension The risk factors are classified and sorted by the risk factors,and the influence degree of the risk factors on the R&D projects is analyzed from three aspects:the risk factors,the risk categories and the demographic differences of the survey subjects.The risk of internal control key points through the expert consultation method the consequences of severity and degree of controllability of the investigation,the expert score on each section familiarity and judgment based on the ratio of the total authority to set the right weight coefficients,controlled study of the seriousness of the internal control and risk key point is completed;and finally,according to the recognized critical control point project risks of drug development Kano properties combined risk score classification and experts,new drug research and development project risk response measures.ResultsIn this study,the risks of R&D project are divided into three categories:technical risk,financial risk,management risk,environmental risk,production risk and market risk.There are 20 sub-risk factors to form risk factors for new R&D project.Based on Kano model A total of 98 valid questionnaires were collected from the questionnaire.The results showed that there was no statistical difference between the two subjects with different gender and job level,and the difference was not significant(P>0.05).The age,educational level,In terms of the number of years of work,the awareness of the impact of some risk factors is slightly different.By using the concept of Kano model two-dimensional concept,the 20 internal control evaluation indexes of the drug R&D personnel for the project risk management are divided into five categories of Kano risk attributes,among which there are 9 attribute risk risks,9 attribute risk attributes,one dimension attribute Risk and reverse risk of each risk,according to the "mandatory attribute>charm attribute>one-dimensional attribute>reverse attribute"risk response priority to develop risk response measures;invited 8 experts from the risk of the consequences of serious and controllable degree of risk assessment Internal control key points of the severity and controllability,according to the five-level quantitative assessment of the risk of internal control key point control is divided into high controllability risk,controllability risk,low controllability risk,low controllability risk 4 grades and applied in the research of risk countermeasures.ConclusionThis study attempts to introduce the Kano quality model into the field of risk management research,use the Kano model attribute characteristics to carry out the risk classification of the new drug R&D project,combine the risk grading severity and the risk controllability level determined by the expert score,and realize the key points of the R&D research on management countermeasures.The research method is scientific,innovative and feasible.The research results are of great practical significance and practical value to improve the R&D capability and risk internal control ability of the new drug risk medicine enterprises,to optimize the allocation of risk management resources and to meet the demand of consumer drugs.In the design of questionnaire entries,should be in accordance with the principles of risk factors to ensure that the investigation of the contents of the comprehensive,streamlined and operational;in the choice of respondents,based on the content and purpose of this study,invited experts with high degree of rigorous scoring,Strong research and development of drug research full-time staff to carry out Kano two-dimensional questionnaire,in order to enhance the rigor of the results and professionalism;In addition,the scientific need to choose the appropriate statistical methods for data processing and analysis.